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The Accu-Chek Safe-T-Pro Plus lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.

The Accu-Chek Safe-T-Pro Plus lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel. The Accu-Chek Safe-T-Pro Plus lancing device is a needle used for capillary blood sampling for use in diagnostic testing. The Accu-Chek Safe-T-Pro Plus lancing device contains a sharps injury prevention feature where the lancet is retracted and concealed before and after use. Once the lancet is used, it is rendered inoperative. The device is designed for single use only. It has a 23 Gauge needle with 3 depth levels by twisting cap: 1.3 mm, 1.8 mm, 2.3 mm. It is spring-driven and loading/priming is not required. Press release button to activate lancet mechanism.

The provided text is a 510(k) premarket notification for the "Accu-Chek Safe-T-Pro Plus Lancing Device". It focuses on establishing substantial equivalence to predicate and reference devices rather than presenting specific acceptance criteria and a detailed study proving the device meets them in the context of performance metrics like sensitivity, specificity, or reader improvement, which are typical for AI/ML devices.

However, based on the information provided, I can extract the non-clinical testing performed and infer the acceptance criteria and details about the study.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria or performance metrics (like accuracy, sensitivity, specificity) for comparison within a table, as one would expect for an AI/ML device. Instead, it describes "nonclinical bench testing" and "design verification and validation testing" to ensure risk management and mechanical function. The "reported device performance" is broadly stated as "performs as well or better than the legally marketed predicate device and legally marketed reference devices."

However, we can infer acceptance criteria related to safety and functionality from the types of testing mentioned and the characteristics of the device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes non-clinical bench testing. It does not provide details on a "test set" in the context of clinical data for performance metrics. For the "nonclinical bench testing," the sample size of devices tested is not specified. The data provenance is also not specified, but it would typically be internal testing conducted by the manufacturer. Since it's bench testing, concepts of retrospective or prospective data usually don't apply in the same way as clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes a physical medical device (lancing device) and its mechanical and safety performance, not an AI/ML algorithm that requires expert-established ground truth for a test set. There is no mention of experts or ground truth in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies involving interpretation of data, often by multiple readers, which is not the case here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a "lancing device," a physical tool for blood sampling. It does not involve AI or software for diagnostic interpretation, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely outside the scope of this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable as the device is a lancing device and does not involve any algorithm or software with standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This section is not applicable. For a lancing device, the "ground truth" for its performance would be its physical properties, sterility, mechanical reliability, and safety features, which are evaluated through engineering tests and quality control, not clinical "ground truth" like pathology or outcomes data in the sense of diagnostic accuracy.

8. The sample size for the training set

This section is not applicable. The device is not an AI/ML product and does not have a "training set."

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

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The Accu-Chek Safe-T-Pro Uno lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.

The Accu-Chek Safe-T-Pro Uno lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

The provided text is an FDA 510(k) premarket notification for the Accu-Chek Safe-T-Pro Uno Lancing Device. It does not describe a study with acceptance criteria in the manner typically found in clinical trials or AI/software validation studies. Instead, it details a "non-clinical bench testing" approach to demonstrate substantial equivalence to a predicate device.

Here's an analysis based on your request, highlighting what is and isn't available in the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance for specific metrics. Instead, it refers to "design verification and validation testing" performed per "applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850)." The conclusion states the device "performs as well or better than the legally marketed predicate device and legally marketed reference devices."

The closest approximation to "device performance" mentioned is:

• The Accu-Chek Safe-T-Pro Uno lancing device is designed for a single use only and has a sharps injury prevention feature where the lancet is retracted and concealed before and after use, and is rendered inoperative after use.
• It uses a 28 Gauge needle with a 1.5 mm depth and is spring-driven.
• Loading/priming is not required; activation is via a press release button.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "sample size used for the test set" or "data provenance" in terms of subject populations or data collection methods (retrospective/prospective). This is because the described testing is "non-clinical bench testing," meaning it was likely conducted in a laboratory setting on the device itself, rather than on human subjects or clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as no "ground truth" established by experts for a test set is mentioned. The testing involves mechanical and design verification, not expert evaluation of results from human or image data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned as there's no expert review of outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. A MRMC comparative effectiveness study is relevant for AI or diagnostic imaging devices evaluating human performance. This document is for a medical device (lancing device) and does not involve AI or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI or algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense of clinical ground truth. The "ground truth" for the non-clinical bench testing would be engineering specifications, regulatory standards (like ISO or FDA special controls for sharps injury prevention), and the performance characteristics of the legally marketed predicate and reference devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary of what is present:

• Type of Study: Non-clinical bench testing (design verification and validation testing).
• Purpose: To demonstrate the mechanical functions, safety (sharps injury prevention), and performance are suitable for use and are substantially equivalent to legally marketed predicate and reference devices.
• Applicable Standards: FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850).
• Conclusion: The device is "safe and effective for its intended use, and performs as well or better than the legally marketed predicate device and legally marketed reference devices."
• Clinical Testing: "Not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately."

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The Accu-Chek Safe-T-Pro Plus lancing device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

The Accu-Chek Safe-T-Pro Plus lancing device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

The provided text is a 510(k) summary for a medical device called the "Accu-Chek Safe-T-Pro Plus Lancing Device." It describes the device, its intended use, and substantial equivalence to a predicate device.

However, the document does not contain any information about acceptance criteria for an AI-powered device, nor does it describe a study involving an AI algorithm.

The document specifically states under "Non-Clinical and/or Clinical Tests Summary & Conclusions":

"Clinical Testing is not applicable; risk analysis confirmed risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable, and communicated in the instructions for use as warnings. There were no special performance or safety concerns identified. See Risk documents provided in Biocompatability section."

Therefore, I cannot provide the requested information about an AI device's acceptance criteria and study proving it meets those criteria based on this document. The device in question is a physical lancing device, not an AI software.

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The Accu-Chek Safe-T-Pro Uno Lancing Device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

The Accu-Chek Safe-T-Pro Uno lancing device is a needle used for capillary blood sampling for use in diagnostic testing. The Accu-Chek Safe-T-Pro Uno lancing device contains a sharps injury prevention feature where the lancet is retracted and concealed before and after use. Once the lancet is used, it is rendered inoperative. The device is designed for single use only.

The provided text describes a 510(k) summary for the Accu-Chek Safe-T-Pro Uno Lancing Device. However, it does not contain specific acceptance criteria, reported device performance metrics, or details about a study that proves the device meets those criteria, such as sample size, data provenance, expert qualifications, or adjudication methods.

The document outlines the device's indications for use, its description, and compares it to a predicate device (SurgiLance Safety Lancets) to establish substantial equivalence. It states that "Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechanical) design verification & validation testing in order to ensure the risks were appropriately managed, in addition to verifying that the device's mechanical functions are suitable for use over the lifetime of the device." A "Verification Summary" is mentioned as an attachment, which presumably contains the detailed test results, but this summary is not provided in the given text.

Therefore, based only on the provided text, I cannot complete the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device rather than detailing a specific performance study with acceptance criteria and results.

Disclaimer: Without the "Verification Summary" mentioned in the document, it is impossible to provide the requested details about acceptance criteria and reported performance. The information below is based solely on what is explicitly stated or can be inferred from the provided text, which is limited regarding specific performance metrics.

Based on the provided text, the following information can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly state specific acceptance criteria or reported device performance metrics in a quantifiable manner. It mentions "nonclinical bench testing" and "design verification & validation testing" were performed to ensure risks were appropriately managed and verify mechanical functions are suitable for use over the lifetime of the device. The conclusion states the device "performs as well or better than the legally marketed predicate device," which is a general statement rather than specific performance data with corresponding acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not provide any information about the sample size used for the test set, data provenance, or whether the study was retrospective or prospective. It only refers to "nonclinical bench testing" and "design verification & validation testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the provided text describes non-clinical bench testing for a lancing device, not a study evaluating human interpretation or a diagnostic algorithm requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the provided text describes non-clinical bench testing for a lancing device and does not involve adjudication of results from multiple reviewers.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as the device is a lancing device and does not involve AI assistance or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a lancing device and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable in the traditional sense of medical image analysis or diagnostic algorithms. For a lancing device, "ground truth" would refer to established engineering and mechanical standards, as implied by "design verification & validation testing" and compliance with "FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850)."

8. The sample size for the training set

This information is not applicable as the device is a lancing device and does not involve machine learning or a training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is a lancing device and does not involve machine learning or a training set.

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The Accu-Chek Softclix Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

This system is for use only on a single patient in a home setting.

This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The Accu-Chek Softclix Lancing Device uses compatible Accu-Chek Softclix Lancets to obtain a drop of blood from a fingertip or alternative sites. The Accu-Chek Softclix Blood Lancing System consists of three components:

1. Accu-Chek Softclix Lancing Device
2. Accu-Chek Softclix Lancets
3. Accu-Chek Softclix Alternative Site Testing (AST) Cap

The provided text describes the regulatory clearance of a blood lancing system and focuses on the substantial equivalence to a predicate device, rather than detailed acceptance criteria and a study proving those criteria.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted as they are not present in this regulatory document. This document emphasizes non-clinical (bench) testing to ensure functional equivalence and risk mitigation for a medical device.

However, based on the information provided, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results. It states that "Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechanical) design verification testing in order to ensure the risks were appropriately managed, in addition to verifying that the device's mechanical functions are suitable for use over the lifetime of the device." This implies that the device met certain mechanical and safety standards but doesn't list specific quantitative criteria or their outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text only mentions "nonclinical bench testing" and "design verification testing" without specifying sample sizes for these tests or the origin of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. As this is a mechanical blood lancing device, "ground truth" in the context of expert review for diagnostic accuracy is not relevant. The testing focuses on mechanical function, safety, and performance as a lancing device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically associated with qualitative or diagnostic assessments, which are not the focus of this device's testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. An MRMC study is relevant for diagnostic imaging or AI-assisted diagnostic devices. This device is a blood lancing system, which does not involve human readers interpreting AI results.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable and not provided. The device described, a blood lancing system, does not involve an algorithm for standalone performance assessment in the way AI systems do. Its performance is mechanical and safety-related.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document explicitly states: "Clinical Testing is not applicable: risk analysis confirmed that all identified risks were addressed and mitigated appropriately." Therefore, ground truth, as often defined for diagnostic accuracy, was not established through clinical data, pathology, or expert consensus on patient outcomes. Instead, the "ground truth" for this device's performance would be adherence to engineering specifications, safety standards (e.g., sharps injury prevention), and mechanical functionality confirmed through bench testing.

8. The sample size for the training set

This information is not applicable and not provided. There is no mention of a "training set" as this is not an AI/ML device that requires training data.

9. How the ground truth for the training set was established

This information is not applicable and not provided, as there is no training set mentioned for this device.

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The Accu-Chek Guide Blood Glucose Monitoring System is comprised of the Accu-Chek Guide meter and the Accu-Chek Guide test strips.

The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.

The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.

The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.

Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Accu-Chek Guide Control Solutions are for use with the Accu-Chek Guide Blood Glucose Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.

The Accu-Chek Guide System consists of the following:

• Accu-Chek Guide meter
• Accu-Chek Guide test strips
• Accu-Chek Guide control solutions (previously cleared in K043474)

The Accu-Chek Guide Blood Glucose Monitoring System makes use of the Accu-Chek Guide test strips, the Accu-Chek Guide meter, and the Accu-Chek Guide control solutions. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. It should be noted that the Accu-Chek Guide control solutions are identical to the Accu-Chek Aviva control solutions that were cleared previously in K043474. The name has simply been updated to reflect their use with the Accu-Chek Guide system.

The provided document describes the ACCU-CHEK Guide Blood Glucose Monitoring System and its performance. However, it does not involve an AI or algorithmic device in the context of medical imaging or diagnosis. Instead, it concerns a blood glucose meter, a device that performs a direct chemical measurement. Therefore, many of the requested categories, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "sample size for the training set," are not applicable as they relate specifically to AI/ML or image interpretation studies.

Here's a breakdown of the relevant information from the document regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood glucose monitoring systems are generally based on accuracy standards, often requiring a certain percentage of results to fall within specified variations from a reference method. The document provides performance data based on differences from a reference measurement. The provided data is not explicitly labeled as "acceptance criteria," but rather as "user performance data." However, these percentages directly describe how well the device performs against established accuracy thresholds. I will present the provided performance data as demonstrating how the device met implied or industry-standard acceptance levels for accuracy.

Summary of Performance:
The "user performance data" and "repeatability (within lot) precision" data demonstrate that the Accu-Chek Guide Blood Glucose Monitoring System meets strong accuracy and precision standards for measuring glucose in various capillary blood samples and with control solutions. For instance, for glucose levels ≥ 75 mg/dL, the device achieves 99.1% of measurements within ±15% and 100% within ±20% for fingertip samples, which are common accuracy targets in the industry. Precision metrics show low CVs, indicating good consistency.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • Fingertip: 12 samples for < 75 mg/dL, 108 samples for ≥ 75 mg/dL.
  • Palm AST: 9 samples for < 75 mg/dL, 363 samples for ≥ 75 mg/dL.
  • Upper Arm AST: 10 samples for < 75 mg/dL, 355 samples for ≥ 75 mg/dL.
  • Repeatability (within lot) precision: 300 measurements for each of 5 blood levels.
  • Control solutions precision: 300 measurements for each of 3 control levels.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, "user performance data" typically implies prospective studies where users perform measurements. The precision studies are laboratory-based. Roche Diabetes Care, Inc. is based in Indianapolis, IN, USA, which is the listed address of the submitter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to a blood glucose monitoring system. The "ground truth" (reference glucose values) is established by a highly accurate laboratory reference method, not by expert interpretation or consensus. No human experts are used to establish "ground truth" in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable to a blood glucose monitoring system. Adjudication methods are relevant for subjective interpretations of data, such as medical images. For blood glucose measurements, the reference method provides a definitive numerical value.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a standalone blood glucose meter for direct measurement, not an AI-powered diagnostic tool requiring human-in-the-loop analysis or comparative effectiveness studies with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance data presented (e.g., user performance, repeatability) are for the device operating in a standalone manner (algorithm only, without human-in-the-loop diagnostic interpretation). The system quantitatively measures glucose based on electrochemical reactions and integrated algorithms to convert the signal to a glucose value. The "human-in-the-loop" aspect for a blood glucose meter refers to the user taking the measurement, not a human clinician interpreting an algorithmic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for blood glucose monitoring systems is established using a highly accurate laboratory reference method for glucose measurement (e.g., YSI analyzer, hexokinase method). This method provides a precise, quantitative biochemical gold standard for glucose concentration.

8. The sample size for the training set

This question is not applicable. Blood glucose meters like the Accu-Chek Guide are based on electrochemistry and fixed algorithms, not machine learning or AI models that require data "training sets." The device's operational parameters and calibration are determined through extensive analytical studies and manufacturing processes, not through a "training set" in the AI sense.

9. How the ground truth for the training set was established

This question is not applicable for the reasons stated in point 8.

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